Nurofen Express Forte 400 mg. 10 capsules

1. What Nurofen Express Forte is and what it is used for

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicinal products provide relief by changing the body's response to pain, swelling and fever.

Nurofen Express Forte is used in adults and adolescents weighing more than 40 kg (12 years and older) for the short-term symptomatic treatment of:

mild to moderate pain such as headache, period pain, toothache

fever and pain associated with cold conditions

You should consult your doctor in case you do not feel better or your condition worsens after 3 days for adolescents or after 3 days for fever or after 4 days for pain in adults.

2. What you need to know before using Nurofen Express Forte

Do not take Nurofen Express Forte

if you are allergic (hypersensitive) to ibuprofen, ponso 4R (E124) or to any of the other ingredients of Nurofen Express Forte (listed in item 6.)

if you have ever suffered from shortness of breath, asthma » runny nose or hives after using acetylsalicylic acid or other similar pain relievers (NSAIDs)

if you suffer or have suffered (two or more separate episodes) from a stomach ulcer or stomach bleeding

if you have had gastrointestinal bleeding or perforation related to NSAID use in the past

if you suffer from unexplained blood cell formation disorders

if you have severe liver, kidney or heart failure or coronary heart disease

during the last 3 months of pregnancy (see section Pregnancy and breastfeeding)

if you suffer from severe dehydration (dehydration caused by vomiting, diarrhea or insufficient fluid intake)

if you have a cerebrovascular haemorrhage or other active haemorrhages)

Do not administer to adolescents under 40 kg or children under 12 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before using Nurofen Express Forte:

if you have an infection — see the "Infections" heading below.

if you suffer from systemic lupus erythematosus (SLE) or mixed connective tissue disease (immune system diseases causing joint pain, skin rash and fever).

if you undoubtedly suffer from a congenital disorder of porphyrin metabolism (e.g. acute intermittent porphyria) or blood clotting problems.

if you suffer or have suffered from a disease of the large intestine (ulcerative colitis or Crohn's disease).

if your kidney function is impaired.

if you have liver disorders.

immediately after major surgery.

shortness of breath may occur if you suffer or have suffered from asthma or other allergic diseases.

if you suffer from hay fever, nasal polyps or chronic obstructive pulmonary disease, due to an increased risk of allergic reactions. They can be expressed as asthmatic attacks (so-called asthma from analgesics), acute swellings (Quincke's edema) or skin rashes.

if you are taking other medicines at the same time that could increase the risk of ulceration or bleeding, such as oral corticosteroids, medicines to thin the blood (eg warfarin), for depression (selective serotonin reuptake inhibitors) or to prevent the formation of blood clots such as acetylsalicylic acid.

Other warnings:

long-term use of pain relievers to treat a headache can make it worse. In such cases, you should stop taking Nurofen Express Forte and consult a doctor.

if you suffer from chickenpox, it is recommended to avoid using Nurofen Express Forte.

with long-term use of Nurofen Express Forte, regular monitoring of liver parameters, kidney function, and blood count is necessary.

the simultaneous use of several NSAIDs, including selective cyclooxygenase-2 inhibitors, may increase the risk of adverse reactions and should be avoided (see Taking other drugs below).

in general, habitual use of (several types of) pain relievers can lead to permanent kidney problems and should be avoided. This risk is further increased by loss of salts and dehydration.

there is a risk of kidney damage in dehydrated adolescents.

Infections

Nurofen Express Forte can hide the signs of infections, for example fever and pain. Therefore, it is possible that Nurofen Express Forte may delay the appropriate treatment of the infection, which may lead to an increased risk of complications. This is seen in pneumonia caused by bacteria and bacterial skin infections associated with chicken pox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, you should consult a doctor immediately.

Skin reactions

Serious skin reactions associated with treatment with Nurofen Express Forte have been reported. You should stop taking Nurofen Express Forte and seek medical attention immediately if you develop a skin rash, mucous membrane lesions, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction. See point 4.

Anti-inflammatory/pain relievers such as ibuprofen may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose and duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking Nurofen Express Forte if:

you have heart problems including heart failure, angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs and feet due to narrowing or blockage of the arteries) or any type stroke (including microstroke or transient ischemic attack “TIA”).

if you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

Adverse reactions can be minimized by using the minimum effective dose for the shortest time. In old age, there is an increased risk of adverse reactions.

Consult your doctor if any of the conditions mentioned above bother you.

Other medicines and Nurofen Express Forte

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Nurofen Express Forte can affect or be affected by some other medicines. For example:

Nurofen Express Forte can affect or be affected by some other medicines. Such as: medicines that are antiplatelet (ie thin the blood/prevent clotting eg acetylsalicylic acid, warfarin, ticlopidine).

medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).

Some other medicines may also affect or be affected by treatment with Nurofen Express Forte. Therefore, you should always seek advice from your doctor or pharmacist before using Nurofen Express Forte with other medicines.

In particular, tell them if you are taking:

other NSAIDs (anti-inflammatories and analgesics) including selective cyclooxygenase-2 inhibitors - may increase the risk of gastrointestinal ulcers and bleeding

digoxin (medicine for heart failure) - due to an increased effect of digoxin

glucocorticoids (medicines containing cortisone or cortisone-like substances) - may increase the risk of gastrointestinal ulcers or bleeding

antiplatelet agents (medicines that suppress platelet aggregation) - may increase the risk of gastrointestinal ulcers or bleeding

phenytoin (medicine for epilepsy) - the effect of phenytoin may be increased

selective serotonin reuptake inhibitors (medicines for depression) - may increase the risk of gastrointestinal bleeding

lithium (a medicine for manic-depressive illness or depression) - may increase the effect of lithium

probenecid and sulfinpyrazone (medicines for gout) - may slow down the elimination of ibuprofen from the body

potassium-sparing diuretics - this can lead to increased levels of potassium in the blood (hyperkalaemia)

methotrexate (medicine used to treat cancer or rheumatism) - the effect of methotrexate may be increased

tacrolimus and cyclosporine (medicines that suppress the immune system) - may cause kidney damage

zidovudine (a medicine used to treat HIV/AIDS) - the use of Nurofen Express Forte may increase the risk of joint bleeding or bleeding leading to swelling in HIV+ haemophiliacs

sulfonylureas (drugs used in diabetes) - interactions are possible

quinolone antibiotics - may increase the risk of seizures

mifepristone (medicine to terminate pregnancy) - the effect of mifepristone may be reduced

acetyl salicylic acid (low doses) - as the blood-thinning effect may be impaired

medicines that thin the blood (such as warfarin), as ibuprofen may increase the effect of these medicines

voriconazole and fluconazole (CYP2C) inhibitors - the effect of ibuprofen m

Driving and using machines

With short-term use in normal doses, this medicinal product has no or negligible influence on the ability to drive and operate machinery. Patients who experience drowsiness, dizziness, vertigo or visual disturbances while taking Nurofen Express Forte should avoid driving and operating machinery. These effects may increase with the simultaneous use of alcohol.

Nurofen Express Forte contains 36.6 mg of sorbitol in each capsule. If your doctor has informed you that you suffer from an intolerance to sugars, consult him before taking this medicinal product.

Nurofen Express Forte contains dye ponzo 4R (E 124), which can cause allergic reactions.

3. How to use Nurofen Express Forte

Always take this medicine exactly as directed in the leaflet. You should contact your doctor or pharmacist if you are not sure about anything. Unless your doctor has prescribed otherwise, the standard dose is:

Dosage:

Adults, children and adolescents weighing more than 40 kg (12 years and older):

As an initial dose: take 1 capsule (400 mg ibuprofen) with water, then if necessary take an additional 1 capsule (400 mg ibuprofen) every 6 hours. Do not take more than 3 capsules (1200 mg ibuprofen) in any 24 hours.

Do not administer Nurofen Express Forte to adolescents under 40 kg (under 12 years).

Application method

For oral use. Do not chew.

It is recommended that patients with a sensitive stomach take Nurofen Express Forte with food. The onset of action of Nurofen Express Forte can be delayed if taken with food. In such cases, do not take a higher dose than recommended in the point "How to take Nurofen Express Forte" until the corresponding time interval between individual intakes has elapsed.

Duration of treatment

This medicinal product is intended for short-term use only.

The lowest effective dose should be used for the shortest possible time needed to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (eg fever and pain) persist or worsen (see point 2).

In adolescents

If in adolescents it is necessary to take Nurofen Express Forte for more than 3 days or the symptoms worsen, you should consult a doctor.

In adults

If it is necessary to take Nurofen for longer than 3 days in the treatment of fever or 4 days in the treatment of pain, or if your symptoms worsen, you should consult a doctor.

Please consult your doctor or pharmacist if you feel that the effect of this medicinal product is greater or less than expected.

If you have taken more than the required dose of Nurofen Express Forte

If you have taken Nurofen Express Forte more than the required dose or if the medicine has been accidentally taken by children, contact a doctor or the nearest hospital immediately to get an opinion on the risk and advice on what action to take.

Symptoms may include nausea (the urge to vomit), vomiting (mixed with blood), blood in the stool (gastrointestinal bleeding), ringing in the ears, headache, stomach pain, diarrhea, and rapid and involuntary eye movements.

In addition, weakness and dizziness, drowsiness, confusion, disorientation, loss of consciousness, feeling cold, chest pain, palpitations, seizures (mainly in children), blood in the urine, and breathing problems have been reported at high doses.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nurofen Express Forte can cause side effects, although not everybody gets them.

Adverse reactions can be minimized by using the lowest effective dose for the shortest time necessary to control symptoms. You may experience some of the side effects of NSAIDs (see below). If this happens or if you have any doubts, stop taking the medicinal product and consult your doctor as soon as possible. In old age, there is an increased risk of adverse reactions.

STOP TAKING this medicinal product and seek medical attention immediately if:

signs of bleeding from the gut such as: cramping pain in the abdomen, traces of blood in the stools, dark colored stools, vomiting with traces of blood or dark, coffee-colored particles.

signs of a very rare but serious allergic reaction such as: worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, fast heart rate, low blood pressure leading to shock. This can happen even at the first intake of the drug.

severe skin reactions such as: rashes all over the body, peeling or peeling of the skin, or blistering.

Other possible side effects

Tell your doctor if any of the following side effects occur or if they get worse, or if you notice other effects that are not

inflammation of the esophagus and pancreas, formation of diaphragm-like intestinal narrowings (diaphragmatic bowel strictures)

serious/severe skin infections and soft-tissue complications have been observed during chicken pox (small pox)

decrease in the normal amount of urine and swelling (especially in patients with high blood pressure or reduced kidney function); swelling (edema) and cloudy urine (nephrotic syndrome); inflammation of the kidneys (interstitial nephritis), which can cause acute kidney failure. If any of these symptoms appear or if you feel severe general fatigue, stop taking Nurofen Express Forte and consult a doctor immediately, as these may be the first signs of kidney damage or kidney failure

problems with the formation of blood cells - the first signs are: high fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe exhaustion, bleeding from the nose and skin. In such cases, you should stop taking the medicinal product and consult a doctor immediately. You should not self-medicate with any painkillers or fever-reducing medicines (angipyretics)

psychotic reactions and depression

Exacerbation of infection-related inflammation (eg, development of necrotizing fasciitis) coinciding with the use of certain pain-relieving drugs (NSAIDs) has been reported. If symptoms of infection appear or worsen while using Nurofen Express Forte, you should contact a doctor immediately. The need for anti-infective/antibiotic treatment should be assessed

high blood pressure, palpitations, heart failure, myocardial infarction

impairment of liver functions, liver damage, especially with long-term use, liver failure, acute inflammation of the liver (hepatitis)

symptoms of aseptic meningitis have been observed, such as: neck stiffness, headache, nausea, vomiting, fever, impaired consciousness during the use of ibuprofen. Patients with existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are predisposed. Consult a doctor immediately if such symptoms occur

severe forms of skin reactions including rash with redness and blistering, (such as Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyle's syndrome), baldness (alopecia)

severe hypersensitivity reactions

exacerbation of asthma and bronchospasm

inflammation of the blood vessels (vasculitis)

Not known (frequency cannot be estimated from the available data)

A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell).

A red, scaly, large-surface rash with subcutaneous bumps and blisters, localized mainly on skin folds, trunk and upper extremities, accompanied by high fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using Nurofen Express Forte if you develop these symptoms and seek medical help immediately. See also point 2.

The skin becomes sensitive to light.

Nurofen Express Forte contains dye ponzo 4R (E 124), which can cause allergic reactions.

Medicines such as Nurofen Express Forte may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke.

5. How to store Nurofen Express Forte

Keep out of the reach of children.

Do not use Nurofen Express Forte after the expiration date marked on the carton and blister. The expiration date corresponds to the last day of the specified month.

To be stored at a temperature below 25°C. Store in original packaging to protect from moisture.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Nurofen Express Forte contains

Each capsule contains 400 mg of ibuprofen. The other ingredients are:

Core:

Macrogol 600, potassium hydroxide, purified water

Capsule shell:

Liquid sorbitol (E 420), gelatin, ponzo 4R (E 124)

Ink:

Propylene glycol, titanium dioxide (E 171), hypromellose (E 464)

Production additives Triglycerides (medium chain)

Lecithin (E 322)

What Nurofen Express Forte looks like and what it contains

The capsules are red, oval and transparent with Nurofen printed in white. The capsules are available in packs of 2,4, 6, 8,10, 12,16, 20,24,30,40 or 50 soft capsules.

Not all pack sizes will be marketed.